Non-invasive Assessment of RECTUM (POUCH) by US (RECT-US) in a Cohort of IBD Patients

Launched by IRCCS SAN RAFFAELE · May 8, 2024

Keywords

ClinConnect Summary

The RECT-US trial is studying how well certain ultrasound techniques can assess the condition of the rectum in patients with inflammatory bowel disease (IBD), specifically those with Crohn's disease or ulcerative colitis. The trial aims to enroll 150 adult participants—50 with Crohn's disease, 50 with ulcerative colitis who have not had surgery to remove their colon, and 50 who have had such surgery and have an ileal pouch. If you have been diagnosed with IBD for at least three months and meet the criteria, you might be eligible to participate.

During the study, you would undergo routine tests, including a type of endoscopy called ileocolonoscopy and two types of ultrasounds, all on the same day. You would also provide blood and stool samples for standard tests. Participation in this trial is voluntary, and all procedures are commonly done in clinical practice, so you can feel comfortable knowing you're receiving familiar care. If you are pregnant or have certain medical conditions, you may not be eligible.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Confirmed diagnosis of IBD for at least 3 months, in particular 50 with Crohn\&;s disease (CD), 50 with ulcerative colitis (UC) not undergoing proctocolectomy, 50 with ulcerative colitis (UC) undergoing proctocolectomy with ileal pouch-anal anastomosis
• • Performing ileocolonoscopy, according to current standards of care and ECCO guidelines, will be assessed by both IUS and TPUS. Procedures performed routinely in clinical practice
• • Ability to understand and comply with the study procedure and sign an informed consent form
• Exclusion Criteria:
• • Pregnancy;
• • Concomitant intestinal infection (e.g. Clostridium difficile);
• • Cirrhosis or intra-abdominal ascites.
• • Subjects not able to comply with any study procedure;
• • Subjects not able to understand and give informed consent form;
• • Subjects with any contraindication to any study procedure.